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FDA 510(k)

MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500

K-Number: K013167 · 2002-01-30

ApplicantNewcare Products, LLC
Decision Date2002-01-30
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500 is the device name listed in this FDA 510(k) record. The listed applicant is Newcare Products, LLC. It received FDA 510(k) clearance on 2002-01-30 under 510(k) number K013167. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500?

MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500 is a medical device that received FDA 510(k) clearance on 2002-01-30. The listed applicant is Newcare Products, LLC. The 510(k) number is K013167.

When did MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500 receive FDA 510(k) clearance?

MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500 received FDA 510(k) clearance on 2002-01-30, under 510(k) number K013167.

Who is the listed applicant for MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500?

The FDA 510(k) record lists Newcare Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500?

The FDA product code for MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500 is GZJ.

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Related Devices (Code: GZJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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